Duns Number:789664455
Device Description: • Simple and fast application technique.• Compatible with all light-cured, and self-cured • Simple and fast application technique.• Compatible with all light-cured, and self-cured restorative materials and cements.• Long shelf-life with no need for refrigeration.• Economical.• No pulp irritation.
Catalog Number
1018
Brand Name
Bonding Agent (Self-Cure) Part A & Part B
Version/Model Number
1018
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012794
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
d4ac9435-27bf-4f64-9c91-a8acc9a57042
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 03, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 59 |